News

Alexion Completes Purchase and License Agreement of Rare Disease Gene Therapy Portfolio from Pfizer

September 21, 2023

The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.

The European Commission Approves Severe Alopecia Areata Treatment

September 21, 2023

Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.

Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

September 21, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

EC Approves Fixed-Dose Oral Combination Treatment for AML

September 20, 2023

Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.

ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry

September 20, 2023

As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.

Genentech Partners with Orionis Biosciences to Discover and Develop Molecular Glue Class Medicines

September 20, 2023

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Samsung Biologics Expands Strategic Manufacturing Agreement with Bristol Myers Squibb

September 20, 2023

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

CN Bio and LifeNet Health LifeSciences Partner to Supply Pre-Validated Cells

September 20, 2023

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Staying Compliant in 2023

September 20, 2023

Leaders at CDER and CBER give update on organizational changes at FDA.

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

September 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.